Trial Outcomes & Findings for Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection (NCT NCT03434678)
NCT ID: NCT03434678
Last Updated: 2025-07-30
Results Overview
Complications will be graded in severity according to the MSKCC Graded Post Operative Complications Criteria based on the modified Dindo, Clavien classification of surgical complications, a grading system commonly used for this procedure.3,4 This classification grades complications from 1-5, with Grade 1 complications requiring bedside intervention. Grade 2 requires moderate interventions, such as intravenous medications. Grade 3 requires either a surgical, endoscopic or interventional radiology procedure for treatment. Grade 4 results in chronic deficit or disability. Grade 5 complications result in death.
COMPLETED
PHASE3
133 participants
90 days post operatively
2025-07-30
Participant Flow
Participant milestones
| Measure |
Epidural-General Anesthesia
Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml: Patient will have their epidural started at the beginning of the surgery and receive fewer opioid drugs. The epidural is continued into the recovery room.
Open Pancreaticoduodenectomy: Whipple' Procedure
|
General Anesthesia
Propofol+ Rocuronium+ Fentanyl + Inhalational: Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room.
Open Pancreaticoduodenectomy: Whipple' Procedure
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
68
|
|
Overall Study
COMPLETED
|
50
|
54
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
| Measure |
Epidural-General Anesthesia
Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml: Patient will have their epidural started at the beginning of the surgery and receive fewer opioid drugs. The epidural is continued into the recovery room.
Open Pancreaticoduodenectomy: Whipple' Procedure
|
General Anesthesia
Propofol+ Rocuronium+ Fentanyl + Inhalational: Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room.
Open Pancreaticoduodenectomy: Whipple' Procedure
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
13
|
|
Overall Study
Found to be ineligible post randomization
|
2
|
1
|
Baseline Characteristics
Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection
Baseline characteristics by cohort
| Measure |
Epidural-General Anesthesia
n=50 Participants
Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml: Patient will have their epidural started at the beginning of the surgery and receive fewer opioid drugs. The epidural is continued into the recovery room.
Open Pancreaticoduodenectomy: Whipple' Procedure
|
General Anesthesia
n=54 Participants
Propofol+ Rocuronium+ Fentanyl + Inhalational: Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room.
Open Pancreaticoduodenectomy: Whipple' Procedure
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
68 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 days post operativelyComplications will be graded in severity according to the MSKCC Graded Post Operative Complications Criteria based on the modified Dindo, Clavien classification of surgical complications, a grading system commonly used for this procedure.3,4 This classification grades complications from 1-5, with Grade 1 complications requiring bedside intervention. Grade 2 requires moderate interventions, such as intravenous medications. Grade 3 requires either a surgical, endoscopic or interventional radiology procedure for treatment. Grade 4 results in chronic deficit or disability. Grade 5 complications result in death.
Outcome measures
| Measure |
Epidural-General Anesthesia
n=50 Participants
Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml: Patient will have their epidural started at the beginning of the surgery and receive fewer opioid drugs. The epidural is continued into the recovery room.
Open Pancreaticoduodenectomy: Whipple' Procedure
|
General Anesthesia
n=54 Participants
Propofol+ Rocuronium+ Fentanyl + Inhalational: Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room.
Open Pancreaticoduodenectomy: Whipple' Procedure
|
|---|---|---|
|
Number of Incidences of Grade 3 or Greater Complications
|
0 Number of complications
|
0 Number of complications
|
Adverse Events
Epidural-General Anesthesia
General Anesthesia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Florence Grant, MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place